Ireland
--:--IST
Recruiting Not applicable

Deafness and Cognition in Middle-aged Adults

NCT05149742 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2022-05-24
Last updated
2025-09-15

Condition(s) studied

Mild Cognitive Impairment in Middle-aged Adults

Investigational drug(s) / intervention(s)

Cognitive and audiometry evaluation

Cognitive and audiometry evaluation: For both Patients and controls: * Cognitive functions evaluation * Tonal and vocal audiometry * Self questionnaires

Study summary

A mild cognitive impairment was observed in 50% of cochlear implant candidates aged 65 years and over, compared to 5-19% in general population. No studies analysed cognition in patients younger than 65 years. The aim of our study was to compare cognitive function between patients with severe and profound hearing loss and patients with normal hearing in patients aged 45 to 64 years.

Eligibility

Sex
ALL
Min age
45 Years
Max age
64 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Cases: Patients aged between 45 to 64 years with severe to profound bilateral post-lingual sensorineural hearing loss with a maximum intelligibility of 70% (disyllabic words) in free-field silence with hearing aids at 60 dB SPL, current in french * Controls: normal hearing subjects matched on age, sex and education level Exclusion Criteria: * Associated disability that prevents the tests from being performed * Past and current history of neurological and psychiatric disorders including meningitis * Psychotropic drug treatment * Vulnerable subject

Primary outcome measure(s)

  • Evaluation of Mini Mental State Examination to access cognitive impairment in patients with severe to profound hearing loss compare to subjects with normal hearing — 1 day
    test to assess cognitive impairment. Result of this test is expressed on 30 points and is analyzed in function of age, sex, education level depending on publicised norms.
  • Evaluation of Trail making tests (TMT) A et B to evaluate executive functions in patients with severe to profound hearing loss compare to subjects with normal hearing — 1 day
    Trail making tests (TMT) A et B: rapidity test to evaluate executive functions. Score is expressed correct displacement number (in A and B parts) divided by time and multiply by ten.
  • Evaluation of "Fluences verbales sémantique et phonémique" to evaluate linguistic skills in patients with severe to profound hearing loss compare to subjects with normal hearing — 1 day
    "Fluences verbales sémantique et phonémique": test to evaluate linguistic skills. Score correspond to the number of words cited in 60 minutes in a specific category.
  • Evaluation of 16-item Free and Cue Selective Recall Test (RLRI/16) to evaluate episodic memory in patients with severe to profound hearing loss compare to subjects with normal hearing — 1 day
    16-item Free and Cue Selective Recall Test (RLRI/16): test adapted in French from the Free and Cue Selective Reminding test (FCSRT) assessing episodic memory. After an encoding phase during which the subject reads and memorizes 16 words 4 by 4, the subject is asked to freely recall as many words as possible in 2 minutes, cues are then provided. The free and cue recall is repeated 3 times and then 20 minutes later (delayed recall). The score used in the study will be: sum of the immediate free recall of the first three trials (0 to 48) and score of the delayed free recall (0 to 16)
  • Evaluation of Digit Symbol Substitution Test to evaluate psychomotor speed and executive functions, executive functions in patients with severe to profound hearing loss compare to subjects with normal hearing — 1 day
    Digit Symbol Substitution Test (DSST) of the Weschsler Adult Intelligence Scale-IV (WAIS-IV): test assessing attention, psychomotor speed and executive functions, executive functions. This test presents a matrix of nine digit-symbol pairs on a sheet of paper. A list of 135 numbers is presented in random order. The subject must associate the symbol corresponding to the number as quickly as possible by following the matrix. The score used will be: number of correctly associated symbols in 90 seconds
  • Evaluation of Instrumental activities of daily living scale to evaluate the level of dependence of dependence of the subjects in patients with severe to profound hearing loss compare to subjects with normal hearing — 1 day
    Instrumental activities of daily living scale (IADL): evaluation of the level of dependence of dependence of the subjects \[45\] (addendum 2). Patients with MCI must remain independent. The existence of dependence contributes to the diagnosis of of dementia
  • Evaluation of Cognitive Complaint Questionnaire to evaluate Cognitive assessment in patients with severe to profound hearing loss compare to subjects with normal hearing — 1 day
    Assessment or monitoring to be instituted for a score of 3 or more, and/or one "yes" answer to question 5, and/or two "yes" answers to questions: A,4,5,7,8.

Trial sites (1)

FacilityCityRegionStatus
Centre de Recherche en Audiologie (CReA) - Groupe Hospitalier Pitié-Salpêtrière Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05149742 on ClinicalTrials.gov ↗ ← All trials in France